Health product recall

G-6-PDH Deficient and Normal Control (2019-03-26)

Starting date:
March 26, 2019
Posting date:
April 9, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-69548



Last updated: 2019-05-17

Affected Products

G-6-PDH Deficient and Normal Control

Reason

Randox is conducting a Field Safety Corrective Action for G6PDH Deficient and Normal Controls for the lots specified in the Field Safety Notice . The target values and ranges are incorrect and are re-assigned. In addition customers are reminded to follow the assay protocol for G6PDH in the Instructions for Use (PD410) and to use the quoted calibration factor to ensure accuracy of results.

Affected products

G-6-PDH Deficient and Normal Control

Lot or serial number

676PD

687PD

700PD

701PD

715PD

716PD

Model or catalog number

PD2617

PD2618

Companies
Manufacturer

Randox Laboratories Ltd.

55 Diamond Road

Crumlin, County Antrim

BT29 4QY

UNITED KINGDOM